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510(k) K840264

SERVO CART 170 by Siemens Elema AB — Product Code BZN

K840264 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SERVO CART 170". The FDA issued a decision of Substantially Equivalent on February 4, 1984. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Siemens Elema AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
January 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device Class
Class I
Regulation Number
868.6175
Review Panel
AN
Submission Type

Other clearances by Siemens Elema AB

  • K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (September 5, 2003)
  • K010923 — KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E (January 23, 2002)
  • K010925 — SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (December 18, 2001)
  • K002137 — CATHCOR DESKTOP (October 5, 2000)
  • K001315 — MODIFICATION TO KION ANESTHESIA SYSTEM (May 26, 2000)
  • K970839 — SERVO VENTILATOR 300A (October 14, 1997)
  • K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 (October 25, 1996)
  • K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE (October 25, 1996)
  • K872278 — SIEMENS O2-AIR MIXER 965 (September 3, 1987)
  • K871354 — SERVO VENTILATOR 900 C/D (July 21, 1987)

Other clearances for product code BZN

  • K924373 — ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP (November 25, 1992)
  • K872558 — CART, EMERGENCY, CARDIOPULMONARY (July 24, 1987)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K832697 — RMP INTUBATION EQUIP. STORAGE TRAY (December 27, 1983)
  • K832356 — PORTABLE OPERAT. RM. MONITORS HS30/40 (October 28, 1983)
  • K832355 — CRASH CART (October 28, 1983)
  • K772320 — EMERGENCY CART (January 3, 1978)

FDA data resources